Article 1U.K.
The Annex to Decision 2002/364/EC is amended in accordance with the Annex to this Decision.
Article 2U.K.
1.This Decision shall apply from 2 March 2021.
2.Notwithstanding paragraph 1, from 2 March 2020 until 1 July 2020 Member States shall apply the presumption of compliance laid down in Article 5(3) of Directive 98/79/EC for all in vitro diagnostic medical devices that comply with any of the following:
(a)the common technical specifications laid down in Decision 2002/364/EC as amended by Commission Decision 2011/869/EU(1);
(b)the common technical specifications laid down in Decision 2002/364/EC as amended by Commission Implementing Decision (EU) 2019/1244(2);
(c)the common technical specifications laid down in Decision 2002/364/EC as amended by this Decision.
3.Notwithstanding paragraph 1, from 2 July 2020 until 1 March 2021 Member States shall apply the presumption of compliance laid down in Article 5(3) of Directive 98/79/EC for all in vitro diagnostic medical devices that comply with either of the following:
(a)the common technical specifications laid down in Decision 2002/364/EC as amended by Implementing Decision (EU) 2019/1244;
(b)the common technical specifications laid down in Decision 2002/364/EC as amended by this Decision.
Article 3U.K.
This Decision is addressed to the Member States.
Done at Brussels, 28 February 2020.
For the Commission
Stella Kyriakides
Member of the Commission